| Trials: PIONEER-AF (n=2124) |
- Rivaroxaban 15 mg daily + P2Y12 inhibitor (mainly clopidogrel)
- Rivaroxaban 2.5 mg twice daily + DAPT (ASA + P2Y12 inhibitor, mainly clopidogrel). Step down to rivaroxaban 15mg daily + P2Y12 inhibitor
- Traditional triple therapy: ASA + clopidogrel + warfarin
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| Primary endpoint |
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Clinically significant bleeding (composite of TIMI major, minor or requiring medical attention) at 12 months
- Rivaroxaban 5 mg daily+clopidogrel: 16.8%
- Rivaroxaban 2.5 mg BID + DAPT: 18.0%
- Traditional triple therapy (ASA+clopidogrel+warfarin): 26.7% (p<0.001 versus both groups 1 and 2)
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| Comments |
- Prevalence of AF: 100%
- Clopidogrel used as the P2Y12 inhibitor in >93% of patients
- Duration of triple therapy for groups and 3 were not randomized (1, 6 or 12 months)
- Most of the reduction in bleeding was in bleeding requiring medical attention with no difference in TIMI major or minor bleeding
- Not powered to detect differences in efficacy
- Use of PPI: <40%
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